Kornimate/medical-research-clean huggingface dataset:
compare continuation of original targeted therapy with trastuzumab combined with pyrotinib and capecitabine as postoperative adjuvant therapy in non-pcr patients with her2 positive early breast cancer

Conditions: Breast Cancer; Adjuvant Therapy

Summary: to evaluate the efficacy of continuation targeted therapy compared with trastuzumab combined with pyrotinib and capecitabine in postoperative adjuvant therapy of her-2 positive early breast cancer patients with residual tumor (primary breast tumor/axillary lymph nodes) who did not achieve pcr after neoadjuvant therapy


Eligibility criteria:
inclusion criteria: * female patients aged ≥ 18 years and ≤ 75 years old with primary breast cancer * ecog score 0 \~ 1 * breast cancer meets the following criteria: 1）histologically or pathologically confirmed invasive breast cancer, primary tumor stage determined by standard evaluation methods：ct1-4/n0-3/m0. 2）pathologically confirmed her2-expressing positive breast cancer, defined as \> 10% immunoreactive cells with immunohistochemical (ihc) score of 3 + or in situ hybridization (ish) results of her2 gene amplification. 3)known hormone receptor status (er and pgr). 4)neoadjuvant therapy (including: at least 9 weeks of trastuzumab treatment and at least 9 weeks of taxane chemotherapy) * primary breast cancer lesion or lymph node invasive cancer confirmed by pathology after neoadjuvant therapy (residual invasive breast cancer lesion \> 2 cm or axillary lymph node positive with macrometastasis assessed by central laboratory) * no more than 12 weeks between end of surgery (without post-operative radiotherapy) and randomisation or 6 weeks between end of post-operative radiotherapy and randomisation * required laboratory values including following parameters: anc: ≥ 1.5 x 109/l platelet count: ≥ 90 x 109/l hemoglobin: ≥ 9.0 g/dl total bilirubin: ≤ 1.5 x upper limit of normal, uln alt and ast: ≤ 1.5 x uln bun and creatine clearance rate: ≥ 50 ml/min lvef: ≥ 55% qtcf: \< 470 ms exclusion criteria: * 1) stage iv (metastatic) breast cancer; * 2) inflammatory breast cancer; * 3) previous anti-tumor therapy or radiotherapy for any malignancy, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma; * 4) receiving anti-tumor therapy in other clinical trials, including bisphosphonate therapy or immunotherapy (except radiotherapy and endocrine therapy during treatment); * 5) receiving any anti-tumor therapy within 28 days before enrollment; * 6) peripheral neuropathy ≥ grade 2 as specified by nci ctcae; * 7) receiving pyrrolidone or other anti-her2 tyrosine kinase inhibitors; * 8) receiving anthracycline therapy with cumulative doses as follows: adriamycin \> 240 mg/m2, epirubicin \> 480 mg/m2; * 9) receiving major surgery unrelated to breast cancer before randomization, or the patient has not fully recovered from surgery
presentations of hypertrophic cardiomyopathy on myocardial perfusion imaging

Conditions: Hypertrophic Cardiomyopathy; Myocardial Perfusion Imaging

Summary: chest pain and myocardial ischemia are prevailing features in patients with hypertrophic cardiomyopathy (hcm). recently introduced single-photon emission computed tomography (spect) cameras with solid-state cadmium-zinc-telluride (czt) detectors have been shown to decrease imaging time and improved the imaging quality of gated myocardial perfusion imaging (mpi). the investigators also correlate the mpi parameters with echocardiographic parameters. this study is to examine the spatial distribution of stress perfusion abnormalities and tissue injury in patients with hcm using a czt spect camera.

the investigators will retrospectively evaluate myocardial perfusion patterns and cardiac function with thallium (tl)-201 gated dipyridamole mpi in patients with clinical diagnosis of hcm and patent coronary angiography between january 2013 and october 2016. the inclusion criteria included a spade-like configuration on left ventriculogram, or echocardiographic findings suggestive of hcm. the participants will be then divided into the following three groups: apical, concentric and septal forms. regional perfusion would be analyzed using a 17-segment model from 0-4 degree (0=normal, to 4=absent perfusion); and summed stress score (sss), summed rest score (srs) and summed difference score (sds) were calculated. gated spect would be processed by quantitative gated spect (qgs) software (cedars-sinai medical center, los angeles, ca, usa) and ejection fraction phase analysis. diastolic parameters would be also acquired by doppler echocardiography, and correlated with mpi parameters.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of hcm and patent coronary angiography between january 2013 and october 2016. exclusion criteria: * patient with prior myocardial ischemia, conduction abnormality, valvular disease or other cardiomyopathy

Keywords: czt scanner myocardial perfusion imaging hypertrophic cardiomyopathy
micropulse laser trabeculoplasty (mlt) versus selective laser trabeculoplasty (slt) for treatment of open angle glaucoma

Conditions: Open Angle Glaucoma

Summary: the purpose of this study is to evaluate the effectiveness of a new laser (called micropulse laser trabeculoplasty or mlt) in the treatment of glaucoma compared to the conventional laser presently used which is called selective laser trabeculoplasty or slt. both lasers (slt and mlt) are used as standard of care in the treatment of open angle glaucoma.

glaucoma is the 2nd leading cause of blindness worldwide and affects over 2.5 million americans over the age of 40. it is thought that elevated intraocular pressure causes damage to the optic nerve fibers which leads to silent vision loss in glaucoma. therefore, the primary approach to managing this disease process is through intraocular pressure reduction with a) topical drops that decrease intraocular fluid production or increase fluid outflow, b) laser therapy to the outflow structures in the eye (trabecular meshwork) to increase fluid egression, c) or incisional surgery with or without placement of setons to create a new pathway for fluid outflow. when medical therapy has been maximized or patients do not tolerate topical therapy, laser trabeculoplasty is common applied to achieve further intraocular pressure reduction. there are two types of laser therapies: argon laser trabeculoplasty (alt) and selective laser trabeculoplasty (slt). the former involves applying laser to create outflow pathways in the trabecular meshwork (tm) and induces thermal damage to the tm. the latter selectively applies energy which induces inflammatory restructuring of the tm without creating a burn. studies have shown comparable results between the two treatment modalities with slt offering the advantage of repeatable treatment. studies have also shown laser trabeculoplasty to be comparable to the effect of topical drops in intraocular pressure reduction. side effects for both types of laser trabeculoplasty include post procedure intraocular pressure elevation and intraocular inflammation which is treated with topical drops after the procedure. this study aims to evaluate the effectiveness of micropulse laser trabeculoplasty in intraocular pressure reduction in patients with open angle glaucoma as compared to conventional selective laser trabeculoplasty. secondary aims would be to determine whether its reduction is comparable to that of topical intraocular pressure lowering drops, length of therapeutic intraocular pressure reduction, and incidence of side effects commonly encountered with traditional laser trabeculoplasty including intraocular inflammation and intraocular pressure spikes.

Eligibility criteria:
inclusion criteria: * patients of any ange age * diagnosis of open angle glaucoma who have not had recent changes in their medication regimen. exclusion criteria: * patients with active neovascularization of the angle, angle closure glaucoma, angle recession, or anterior uveitis

Keywords: glaucoma micropulse laser trabeculoplasty open angle intraocular pressure
acceptability of a new paediatric formulation of hydroxycarbamide in children with sickle cell disease.

Conditions: Sickle Cell Disease

Summary: this is a prospective, interventional, phase ii, open-label, multicentre, national, non-comparative study of a single administration of the new dispersible form of hydroxycarbamide at the usual dose in children with sickle cell disease who are already treated with the current form of hydroxycarbamide (siklos® 100 mg and/or 1000 mg film-coated tablets).


Eligibility criteria:
inclusion criteria: * written informed consent, signed and dated by both parents or by the legally acceptable representative(s) of the children, * child with sickle cell disease, treated with 100 mg and/or 1000 mg siklos® film-coated tablets at the same daily dose for more than 4 weeks, * child aged between 2 and 6 years old, * parents capable of communicating with the investigator and understanding the requirements and constraints of the study protocol and willing to comply with the study requirements, * children affiliated to a social security plan (including universal health coverage) or beneficiary of a similar insurance plan. exclusion criteria: * participation in any other clinical study for any other pharmaceutical product within 4 weeks preceding study inclusion, * known hypersensitivity or allergy to the excipients, * any surgical or medical condition or any significant illness (of which severe hepatic impairment (child-pugh classification c), severe renal impairment, toxic ranges of myelosuppression) that, in the opinion of the investigator, constitutes a risk or a contraindication to the participation of the patient to the study, or that may interfere with the objectives, conduct or evaluation of the study.

Keywords: hydroxycarbamide pediatric acceptability
the effect of ruboxistaurin on small fiber function

Conditions: Diabetic Neuropathy

Summary: to determine the effect of ruboxistaurin on small fiber function.


Eligibility criteria:
inclusion criteria: * patients must have type 1 or type 2 diabetes mellitus * patients must have bilateral sensorimotor distal peripheral neuropathy attributable to diabetes mellitus * patients must have blood glucose control measured as hba1c=\<11% * patients must be 18 years of age or older. * patients must be able to return to all follow-up visits exclusion criteria: * patients must not have symptoms of diabetic peripheral neuropathy that cannot be distinguished from other etiologies * patients must not have a neurologic disease or neuropathy from a cause other than diabetes mellitus that would interfere with correct evaluation of symptomatic peripheral neuropathy. * patient currently has uncontrolled high blood pressure * you have other medical problems that your doctor feels would make it unsafe for you to participate in this study such as liver or kidney problems * you are a woman of childbearing age and unwilling or unable to use effective contraceptive.
a randomized controlled trial of a school disinfection and hand hygiene program

Conditions: Respiratory Infections; Gastrointestinal Diseases

Summary: the objective of the trial is to assess the impact of a disinfection and hand hygiene program on absenteeism in elementary school classrooms. students in intervention classrooms will use alcohol-based hand sanitizers at school, and their classrooms will be disinfected using quaternary ammonium wipes. we hypothesize that the use of disinfectants and hand hygiene products in elementary school classrooms will reduce absenteeism.


Eligibility criteria:
inclusion criteria: * member of a designated elementary school classroom in the avon school system

Keywords: prevention of gastrointestinal and respiratory illness
study based on electronic health records to identify patients at high-risk of fabry disease (hope fabry)

Conditions: Fabry Disease

Summary: primary objective: to estimate the prevalence of patients who are at high-risk for fabry disease (fd) in the cleveland clinic, abu dhabi (ccad) united arab emirates (emr) database from may 2016 to may 2022, according to the predictive algorithm (i.e., feasibility assessment eligibility criteria) secondary objectives: * to estimate the prevalence of fd among patients at high-risk for fd (i.e., among enrolled patients) * to characterize the patient profile, overall and in cohorts 1 and 2 * to describe the most common characteristics among positive fd patients and negative fd patients

patients at high-risk for fd will be consecutively enrolled over approximately 6 months

Eligibility criteria:
inclusion criteria: * patients who were identified as high-risk for fd via the predictive algorithm per the feasibility assessment * patients who have signed an informed consent form cohort 1 (chronic kidney disease) * adult male patient ≤60 years old or adult female patient of any age * having chronic kidney disease * having proteinuria * having one or more of the following conditions: * neuralgia and neuritis, unspecified * disturbances in skin sensation * anhidrosis, and * hypertrophic cardiomyopathy. cohort 2 (hypertrophic cardiomyopathy) * adult male patient ≤50 years old or adult female patient of any age * having hypertrophic cardiomyopathy * having one or more of the following conditions: * transient cerebral ischemic attack, * chronic kidney disease. exclusion criteria: * patients with an established diagnosis of fd. * pregnant subject at the time of the study. the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
evolution of the energy expenditure during hematopoietic stem cell transplantation

Conditions: Bone Marrow Transplantation; Hematopoietic Stem Cell Transplantation

Summary: the treatment before bone marrow transplantantion is initiated by chemotherapy associated or not with radiotherapy, both of which cause various side effects on the patient as symptoms that impair food intake. the nutritional status of the patient is one of the factors related to the success of the transplant, so a complete nutritional assessment before transplantation is necessary in order to identify patients at nutritional risk, nutritional disorders and to perform appropriate and early intervention to promote recovery and / or health maintenance. will be used for nutritional assessment: arm perimeter, arm muscle area; electrical bioimpedance, phase angle, and indirect calorimetry, a standard method of noninvasive nutritional assessment that expresses the nutritional demand and rate of utilization of energy substrates from oxygen consumption and carbon dioxide production through the air inhaled and exhaled by the individual's lungs.


Eligibility criteria:
inclusion criteria: * patients with hematological disease * age equal or superior to 15 years old * both sexes * will be submitted bone marrow transplantation exclusion criteria: * age below 15 years old * those who can't perform calorimetry (oxygen therapy, mechanical ventilation) * have hyper or hypothyroidism * admitted to the intensive care unit (without at least one result of post-transplant indirect calorimetry) * don't agree to participate in the study

Keywords: bone marrow transplantation hematopoietic stem cell transplantation indirect calorimetry energy metabolism basal metabolism
asymptomatic small pancreatic endocrine neoplasms.

Conditions: Non Functioning Pancreatic Endocrine Tumor

Summary: the aim of the study is to evaluate the most appropriate management of sporadic asymptomatic non-functioning pancreatic neuroendocrine neoplasms (nf-pnen) ≤ 2 cm. p nf-pnen management will be decided at the hospital and all therapeutics decision will be decided/coordinated by the treating physician. patients will be either submitted to surgical resection or to active surveillance.

in the last decade a dramatic increase in diagnosis of small, incidentally discovered, nf-pnen was observed. various study indicates the safety of a conservative management for this lesion and the the european neuroendocrine tumor society (enets) proposed a "wait and see" approach for small nf-pnen. indications for surgery include the presence of a localized nf-pnen in the absence of distant metastases as curative resection of these tumors is associated with favourable prognosis especially for low grade. in the last decade a dramatic increase in diagnosis of small, incidentally discovered, nf-pnen was observed.moreover, other investigators observed a clear relationship between the tumor diameter and low risk of malignancy and systemic progression. in particular, a tumor size ≤ 2 cm seems to be associated with a negligible risk of disease recurrence and with a very low incidence of aggressive features such as lymph node involvement.on this basis, the european neuroendocrine tumor society (enets) proposed a "wait and see" approach for small nf-pnen when incidentally discovered. since then, various series evaluated the safety of a conservative management for small, sporadic, incidentally diagnosed, nf-pnen. after a median follow-up of 28-45 months, all the studies confirmed that an intensive surveillance for incidental and small nf-pnen is safe in selected cases. nevertheless, available data are based only on retrospective series with a significant heterogeneity of inclusion criteria and different tumor diameter cut-off and the appropriate management of this entities (surveillance versus surgery) is still a matter of debate.

Eligibility criteria:
inclusion criteria: * age \> 18 years * individuals with asymptomatic sporadic nf-pnen ≤ 2 cm * diagnosis has to be proven by a positive fine-needle aspiration (fna) or by the presence of a measurable nodule on high-quality imaging technique (ct or mr) that is positive at 68gallium dotatoc-pet scan or octreoscan. * patients who undergo surgery for nf-pnen\<2cm within 12 months. in these cases, diagnosis has to be proven by histological confirmation of nf-pnen * informed consent exclusion criteria: * nf-pnen \> 2 cm of maximum diameter * presence of genetic syndrome (men1, vhl, nf) * presence of symptoms (specific symptoms suspicious of a clinical syndrome related to hypersecretion of bioactive compounds) or unspecific symptoms

Keywords: nf-pnen
effects of ledipasvir/sofosbuvir on the pharmacokinetics and renal safety of tenofovir alafenamide (taf)

Conditions: Hepatitis C; HIV Coinfection

Summary: this study will evaluate the effect of ledipasvir/sofosbuvir (ldv/sof) treatment on the pharmacokinetics (pk) and renal safety of tenofovir in the form of tenofovir alafenamide (taf). subjects living with human immunodeficiency virus (hiv) who are receiving tenofovir-based antiretroviral therapy (in the form of tenofovir disoproxil fumarate \[tdf\]), and are also taking a ritonavir- or cobicistat-boosted protease inhibitor will be invited to participate. the study will consist of five visits: a screening visit, three abbreviated 4-hour pharmacokinetic visits, and one end-of-study follow-up visit. subjects will also be asked to use a wisepill device, which will track medication adherence throughout the study.


Eligibility criteria:
inclusion criteria: * between 18-70 years of age * have been taking tdf and a ritonavir- or cobicistat-boosted protease inhibitor as part of standard care for treatment of hiv exclusion criteria: * egfr \< 30 ml/min * pregnant or planning pregnancy * breastfeeding * any medical, social, or mental-health issue(s) that, in the opinion of the investigators, could interfere with study participation or the study outcomes * signs or symptoms of decompensated liver disease * hepatitis b infection * medications that may cause unwanted drug interactions with ledipasvir/sofosbuvir or emtricitabine/tenofovir alafenamide * unwillingness or inability to comply with study procedures * chronic hepatitis c infection
use of iron isomaltoside 1000 (monofer) in postpartum anemia

Conditions: Postpartum Anemia

Summary: the investigators hypothesized that both isomaltoside 1000 (monofer), and oral iron preparation will be equally effective in correction of postpartum iron deficiency anemia.

iron molecule iron isomaltoside 1000 (monofer) have been introduced in the market, which can be given in intravenous infusion forms, in a relatively short period of time, in a single setting, after calculation of the required dose. this preparation has been used for treatment of anemia in patients with chronic renal disease, gastrointestinal disorders, anemia of malignancy and in gynecological disorders. it does not require a test dose to be given before total dose, nor does it require any premedication. it can be given in a dose of 20mg/kg. the drug has been licensed for use in europe in 2009. it has been used for treatment of anemia in patients with chronic renal disease, inflammatory bowel disease and in anemia due to malignancies

Eligibility criteria:
inclusion criteria: * women within 24-48 hours of delivery with hemoglobin concentration \< 10gm/dl exclusion criteria: * history of pph, or significant blood loss in last 24 hours * history of allergy to iron preparation * hemoglobin \< 7gm/dl. * sign \& symptoms of cardiac failure * h/o blood transfusion in last 3 months * h/o chronic liver diseases. * ↑ creatinine \> 2mg/dl.

Keywords: iron monofer pakistan
urodynamics of suprasacral spinal cord injury patients

Conditions: Spinal Cord Injuries

Summary: the medical records of 215 patients with spinal cord injury(sci) at the department of rehabilitation medicine of the 2nd affiliated hospital of wenzhou medical university, wenzhou, china were evaluated between january 1, 2016 and december 20, 2019. according to the inclusion criteria and exclusion criteria, 101 patients were included. the patients were dichotomized into two groups: complete sci group and incomplete sci group, based on the american spinal injury association guidelines impairment scale (ais) .the investigators retrospectively collected records of urodynamic evaluations of this patients and then analyze the urodynamic parameters,including detrusor overactivity (do), bladder compliance (bc), bladder-filling sensation, maximum cystometric capacity (mcc), detrusor external sphincter dyssynergia (desd), maximum urinary flow rate (qmax), detrusor pressure at a maximum urinary flow rate(pdetqmax).


Eligibility criteria:
inclusion criteria were: 1. the period of the spinal shock has passed. 2. patients diagnosed with traumatic suprasacral sci, based on ais. 3. urodynamic investigations were performed by the same urologist. 4. patients with voiding dysfunction. exclusion criteria: the patient with voiding dysfunction before the injury were excluded.
heath-related quality of life of diabetic transmetatarsal amputees and below-knee prosthetic users

Conditions: Amputees; Diabetes Complications

Summary: the present study assesses the health-related quality of life of diabetic transmetatarstal and below-knee prosthetic user. the study design is cross-sectional with a retrospective review of patient hospital records and an assessment with patient-reported outcome measure.

the present study aims to recruit 100 diabetic transmetatarsal and below-knee prosthetic user to assess the health-related quality of life (hrqol) between these two patient groups. the 15d hrqol instrument is applied. an additional comparison with the age-standardized finnish general population will be performed.

Eligibility criteria:
inclusion criteria: * patients with diabetes * transmetatarsal amputation * below-knee prosthetic user * 2-5 years from surgery exclusion criteria: * no diabetes * other than transmetatarsal or below-knee amputation * below-knee amputation but not a below-knee prosthetic user * less than 2 years from the amputation * over 5 years from amputation

Keywords: diabetes amputation below-knee transmetatarsal [m01.150.100] [c19.246.099]